Skills
Commissioning, Qualification & Validation (CQV)
• Equipment & Utility Qualification (Autoclaves, HVAC, CIP/SIP, Purified Water Systems)
• Computer System Validation (CSV) – GAMP 5, 21 CFR Part 11
• Process Validation & Cleaning Validation
• Validation Master Plan (VMP) Development
• IQ/OQ/PQ Protocol Preparation & Execution
• Deviation, CAPA & Change Control Management
• Risk Assessment (FMEA, URS, Traceability Matrix)
• cGMP, GLP, GDP Compliance
• Technical Documentation & Audit Readiness
• FDA, EMA, and ICH Regulatory Compliance
• Project Lifecycle Management (URS to PQ)
• Root Cause Analysis & Continuous Improvement
• Data Integrity & Electronic Records Compliance
• Team Coordination & Cross-Functional Communication
About
Results-driven Senior Validation Engineer with extensive experience in pharmaceutical and biotech manufacturing environments, specializing in Commissioning, Qualification, and Validation (CQV) of equipment, utilities, and computerized systems. Proven expertise in executing IQ/OQ/PQ protocols, managing change control, deviations, and risk assessments, and ensuring full compliance with FDA, cGMP, and GAMP 5 standards. Recognized for strong technical documentation, cross-functional collaboration, and ability to deliver compliant, audit-ready systems on schedule.
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